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RTF Template

State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	0775
2. Name of Authorisation Holder	:	UAB "SANOFI-AVENTIS LIETUVA"
3. Address(es) of Site(s)	:	A. Juozapavičiaus g. 6, Vilniaus m., Vilniaus m. sav., LT-09310, Lithuania

4. Legally registered address of Authorisation Holder	:	A. Juozapavičiaus g. 6, Vilniaus m., Vilniaus m. sav., LT-09310, Lithuania
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2008-12-16
10. Annexes attached	:	Annex 1 Scope of wholesale distribution authorisation Annex 2 (Optional) Address(es) of contract wholesale distribution sites and their authorisation number Annex 3 (Optional) Name(s) of responsible person(s) Annex 4 (Optional) Date of Inspection on which authorisation was granted Annex 5 (Optional) Additional provisions based on national requirements

ANNEX 1

SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION

Name and address of the site: UAB "SANOFI-AVENTIS LIETUVA"

, A. Juozapavičiaus g. 6, Vilniaus m., Vilniaus m. sav., LT-09310, Lithuania

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation in EEA country(s)

1.2. without a Marketing Authorisation in the EEA and intended for EEA market

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: Herbal medicinal products Augaliniai preparatai

Any restrictions or clarifying remarks (for all users): Agreement on distribution service of 21 November 2012 with Oribalt Vilnius, UAB, Laisvės pr. 75, Vilniaus m., Vilniaus m. sav., Lithuania (Wholesale Distribution Authorisation No. 0102). Wholesale distribution operations performed according to the agreement: reception of medicinal products, holding (warehousing), collection and transportation.
Agreement on service of 13 August 2018 with UAB „ENTAFARMA", Klonėnų vs. 1, Jauniūnų sen., Širvintų r. sav. Lithuania (Wholesale Distribution Authorisation No. 0105). Wholesale distribution operations performed according to the agreement: reception, holding (warehousing), collection and transportation of medicinal products.

2012-11-21 platinimo paslaugų sutartis su Oribalt Vilnius, UAB, Laisvės pr. 75, Vilniaus m., Vilniaus m. sav., (Didmeninio platinimo licencija Nr. 0102). Pagal sutartį vykdomi didmeninio platinimo veiksmai : vaistinių preparatų priėmimas, laikymas (saugojimas), surinkimas ir transportavimas.
2018-08-13 platinimo paslaugos sutartis su UAB „ENTAFARMA", Klonėnų vs. 1, Jauniūnų sen., Širvintų r. sav. (Didmeninio platinimo licencija Nr. 0105). Pagal sutartį atliekami didmeninio platinimo veiksmai : vaistinių preparatų priėmimas, laikymas (saugojimas), surinkimas ir transportavimas.

*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

**Without prejudice to further authorisations as may be required according to national legislation

Union Format for a Wholesale Distribution Authorisation	0775
	Page 1

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